# K021932: Synthes 6.5 MM Cannulated Screw

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Sep 6, 2002 after 86 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
755 later devices descend from it; 62 cite it directly.
1 of 756 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Synthes 7.3 mm Cannulated Screw: named in the summary without a submission number
- (no number) Alphatec 6.5 Cannulated Screw: named in the summary without a submission number

## Most influential descendants
- K102903: Pioneer Cannulated Screw System (2010), 309 descendants of its own
- K102907: Simmetry Sacroiliac Joint Fusion System (2010), 245 descendants of its own
- K110512: Simmetry Sacroiliac Joint Fusion System (2011), 241 descendants of its own
- K111801: Simmetry (TM) Sacroiliac Joint Fusion System (2011), 240 descendants of its own
- K112028: SI-Lok Sacroiliac Joint Fixation System (2011), 238 descendants of its own

## Recalls of this device
- Feb 16, 2016 · Class II · Z-2156-2016: Labeling does not match the cleared indications for use in the United States and Canada.
- Feb 16, 2016 · Class II · Z-2153-2016: Labeling does not match the cleared indications for use in the United States and Canada.
- Feb 16, 2016 · Class II · Z-2154-2016: Labeling does not match the cleared indications for use in the United States and Canada.
- Feb 16, 2016 · Class II · Z-2155-2016: Labeling does not match the cleared indications for use in the United States and Canada.
- Feb 16, 2016 · Class II · Z-2157-2016: Labeling does not match the cleared indications for use in the United States and Canada.
- Feb 16, 2016 · Class II · Z-2152-2016: Labeling does not match the cleared indications for use in the United States and Canada.
- Feb 16, 2016 · Class II · Z-2158-2016: Labeling does not match the cleared indications for use in the United States and Canada.

## Indications for use
Synthes 6.5 mm Cannulated Screw is intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basilar neck fractures; tibial plateau fractures; ankle arthrodeses; pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodeses.

Source page: https://510kreport.com/device/K021932
Methodology: https://510kreport.com/methodology